Devices and Methods for Preparing A Transcatheter Heart Valve System

ABSTRACT

Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.

BACKGROUND

The present disclosure relates to transcatheter heart valve systems.More particularly, it relates to devices and methods for preparing atranscatheter heart valve system for implanting a stented prostheticheart valve.

Heart valves, such as the mitral, tricuspid, aortic, and pulmonaryvalves, are sometimes damaged by disease or by aging, resulting inproblems with the proper functioning of the valve. Heart valve problemsgenerally take one of two forms: stenosis in which a valve does not opencompletely or the opening is too small, resulting in restricted bloodflow; or insufficiency in which blood leaks backward across a valve whenit should be closed.

Heart valve replacement has become a routine surgical procedure forpatients suffering from valve regurgitation or stenotic calcification ofthe leaflets. Conventionally, the vast majority of valve replacementsentail full stenotomy and placing the patient on cardiopulmonary bypass.Traditional open surgery inflicts significant patient trauma anddiscomfort, requires extensive recuperation times, and may result inlife-threatening complications.

To address these concerns, within the last decade, efforts have beenmade to perform cardiac valve replacements using minimally-invasivetechniques. In these methods, laparoscopic instruments are employed tomake small openings through the patient's ribs to provide access to theheart. While considerable effort has been devoted to such techniques,widespread acceptance has been limited by the clinician's ability toaccess only certain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheter(or transluminal) delivery of replacement cardiac valves to solve theproblems presented by traditional open surgery and minimally-invasivesurgical methods. In such methods, a prosthetic heart valve is compactedfor delivery in a catheter and then advanced, for example through anopening in the femoral artery and through the descending aorta to theheart, where the prosthetic heart valve is then deployed in the valveannulus (e.g., the aortic valve annulus).

Various types and configurations of prosthetic heart valves are used intranscatheter valve procedures to replace defective natural human heartvalves. The actual shape and configuration of any particular prostheticheart valve is dependent to some extent upon the valve being replaced(i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve).In general, prosthetic heart valve designs attempt to replicate thefunction of the valve being replaced and thus will include valveleaflet-like structures used with either bioprostheses or mechanicalheart valve prostheses. If bioprostheses are selected, the replacementvalves may include a valved vein segment or pericardial manufacturedtissue valve that is mounted in some manner within an expandable stentframe to make a valved stent (or stented prosthetic heart valve). Inorder to prepare such a valve for transcatheter implantation, one typeof valved stent can be initially provided in an expanded or uncrimpedcondition, then crimped or compressed around a balloon portion of acatheter until it is close to the diameter of the catheter. In othertranscatheter implantation systems, the stent frame of the valved stentcan be made of a self-expanding material. With these systems, the valvedstent is crimped down to a desired size and held in that compressedstate with a sheath, for example. Retracting the sheath from this valvedstent allows the stent to expand to a larger diameter, such as when thevalved stent is in a desired position within a patient. With either ofthese types of percutaneous stent delivery systems, conventional sewingof the prosthetic heart valve to the patient's native tissue istypically not necessary.

The transcatheter delivery system (e.g., the delivery device catheterloaded with a stented prosthetic heart valve) must be free of airbubbles to prevent formation of air embolisms during the implantationprocedure. Conventionally, air bubbles are removed by repeatedlyflushing the system with a liquid (e.g., saline) to remove air from thesystem just prior to the implantation procedure. Traditional flushingrelies on pushing liquid through the lumen(s) of the delivery devicecatheter to move bubbles out of the system. This can be difficult withthe exceedingly small lumens associated with transcatheter deliverysystems, and as the stented prosthetic heart valve is loaded into thecatheter, new bubbles can be introduced that are difficult to removewithout further flushing.

In light of the above, a need exists for improved devices and methodsfor preparing transcatheter heart valve systems, including removal ofair bubbles.

SUMMARY

Some aspects in accordance with principles of the present disclosure aredirected toward an assembly for loading and delivering a stentedprosthetic heart valve. The assembly includes a delivery device and avalve loading device. The delivery device can assume a wide variety offorms, and generally includes a tube and a shaft. The tube terminates ata distal end and defines at least one lumen. The shaft is disposedwithin the lumen and is connected to a tip. The tip, in turn, is locateddistal the distal end. The valve loading device includes a housing,first and second sealing apparatuses, and a port. The housing forms achamber and terminates at opposing, first and second ends. An opening tothe chamber is defined at both of the ends. The first sealing apparatusis associated with the first end and is configured to selectivelysealingly engage the tip. The second sealing apparatus is associatedwith the second end and is configured to selectively sealingly engagethe tube. Finally, the port is open to the chamber. With thisconstruction, the assembly is configured to provide a flushing state inwhich a stented prosthetic heart valve is seated within the chamber andthe valve loading device is assembled to the delivery device. A negativepressure can then be generated in the chamber, and air bubbles removedfrom the delivered liquid, via the port. In related embodiments, theassembly is configured to provide a loading state in which the chamberis at least partially filled with liquid free of bubbles and thedelivery device is operable to load the stented prosthetic heart valve.In other embodiments, the assembly is configured to provide a deliverystate in which the valve loading device is removed from the deliverydevice such that the delivery device can be used to deliver a loadedstented prosthetic heart valve.

Other aspects in accordance with principles of the present disclosurerelate to a valve loading device for flushing and loading atranscatheter heart valve system. The transcatheter heart valve systemincludes a stented prosthetic heart valve and a delivery device. Withthis in mind, the valve loading device includes a housing, first andsecond sealing apparatuses, and a port. The housing forms a chamber andterminates at opposing, first and second ends. An opening to the chamberis defined at both of the ends. The first sealing apparatus isassociated with the first end and is configured to selectively sealinglyengage the delivery device. The second sealing apparatus is associatedwith the second end and is configured to selectively sealingly engagethe delivery. Finally, the port is open to the chamber. The valvedelivery device is configured to temporarily retain a stented prostheticheart valve within the chamber and for temporary assembly to thedelivery device such that entrained air bubbles in liquid delivered tothe chamber is removed via a negative pressure established through theport. In some embodiments, a check valve is assembled to the port, andthe sealing apparatuses each include a Tuohy-Borst valve.

Yet other aspects in accordance with principles of the presentdisclosure relate to a method of preparing a transcatheter heart valvesystem including a stented prosthetic heart valve and a delivery device.The method includes seating the stented prosthetic heart valve within achamber defined by a housing of a valve loading device. In this regard,the housing extends between opposing, first and second ends, and definesan opening to the chamber at each of the ends. A first component of adelivery device is connected to the stented prosthetic heart valve. Thefirst and second openings are sealed relative to the delivery device. Aliquid is dispensed through the delivery device and into the chamber.Entrained air bubbles in the so-delivered liquid are removed to flushthe delivery device. The stented prosthetic heart valve is capturedwithin the delivery device and the valve loading device is removed fromthe delivery device. With methods of the present disclosure, a loaded,air bubble-free transcatheter heart valve system is prepared for animplantation procedure. In some embodiments, the housing includes firstand second housing sections, with the step of seating the prostheticheart valve within the chamber including removing the first housingsection from the second housing section, locating the prosthesis withinthe second housing section, and then assembling the first housingsection to the second housing section to complete the chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are diagrams illustrating basic components of atranscatheter heart valve system and with which device and methods ofthe present disclosure are useful;

FIG. 2A is a side view of a stented prosthetic heart valve useful withthe system of FIGS. 1A-1C and in a normal, expanded arrangement;

FIG. 2B is a side view of the stented prosthetic heart valve of FIG. 2Ain a compressed arrangement;

FIG. 3 is a simplified cross-sectional view of a valve loading device inaccordance with principles of the present disclosure; and

FIGS. 4A-4E illustrate use of the valve loading device of FIG. 3 inpreparing the system of FIG. 1B for an implantation procedure inaccordance with principles of the present disclosure.

DETAILED DESCRIPTION

Aspects of the present disclosure relate to devices, and correspondingmethods of use, for preparing a transcatheter heart valve system. Whilean exact configuration of the transcatheter heart valve systemcomponents is not critical to features of the present disclosure, thefollowing explanation of an exemplary transcatheter heart valve systemcan be useful to better understand the devices and methods of thepresent disclosure.

One example of a transcatheter heart valve system 20 with which devicesand methods of the present disclosure are useful is shown in simplifiedform in FIGS. 1A-1C, and includes a stented prosthetic heart valve 22and a delivery device 24. In general terms, the delivery device 24 isconfigured to deliver the stented prosthetic heart valve 22 to animplantation site in performing a therapeutic procedure on a defectiveheart valve of a patient.

The stented prosthetic heart valve 22 can assume a wide variety forms.In general terms, and with additional reference to FIGS. 2A and 2B, thestented prosthetic heart valve 22 includes a stent or stent frame 30 anda valve structure 32. The stent frame 30 can be constructed to beself-expandable from a compressed arrangement (FIG. 2B) to a natural,expanded arrangement (FIG. 2A) (e.g., formed of shape memory materialsuch as a nickel titanium alloy). Alternatively, a separate expansionmember can be employed (e.g., an expansion balloon). The valve structure32 forms or provides two or more (typically three) leaflets 34 a, 34 b.The leaflets 34 a, 34 b (as well as other portions of the valvestructure 32) can be formed from autologous tissue, xenograph material,or synthetics. The leaflets 34 a, 34 b can be provided as a homogenous,biological valve structure, such as porcine, bovine or equine valves.Alternatively, the leaflets 34 a, 34 b can be provided independent ofone another (e.g., bovine or equine paracardial leaflets) andsubsequently assembled to the stent frame 30.

The stented prosthetic heart valve 22 can be viewed as defining aninflow region 40 and an outflow region 42. As a point of reference,“inflow” and “outflow” terminology is in reference to an arrangement ofthe stented prosthetic heart valve 22 upon final implantation relativeto the native valve being repaired or replaced. The valve structure 32is located along the inflow region 40. The stent frame 30 can form orcarry one (or more) connection bodies 44 (e.g., tabs, crowns, posts,etc.) at one or both of the inflow and outflow regions 40, 42 forconnection with the delivery device 24 as described below. Non-limitingexamples of stented prosthetic heart valves envisioned by the presentdisclosure are sold under the tradename CoreValve® available fromMedtronic CoreValve, LLC, as well as those described in US PublicationNos. 2006/0265056, 2007/0239266 and 2007/0239269, the teachings of whichare incorporated herein by reference.

The delivery device 24 can also assume a wide variety of forms, and isgenerally configured to retain the stented prosthetic heart valve 22 inthe compressed arrangement (e.g., FIG. 1B), and selectively release thestented heart valve 22 at the implantation site (partially reflected byFIG. 1C). With this in mind, the delivery device 24 includes a shaftassembly 50 and a sheath assembly 52. The shaft assembly 50 includes acarrier shaft 54 (also referred to as a middle portion or intermediateportion of the shaft assembly 50), a connector shaft 56 (also referredto as a distal portion of the shaft assembly 50), a tip (e.g., a nosecone) 58, and a handle 60. The connector shaft 56 interconnects thecarrier shaft 54 and the tip 58, and in some constructions has a reducedouter diameter to permit placement of the stented prosthetic heart valve22 over the connector shaft 56.

The carrier shaft 54 is sized to be slidably received within a portionof the sheath assembly 52, and is configured in the illustratedembodiments for releasable coupling with the stented prosthetic heartvalve 22. For example, the carrier shaft 54 can form or including acoupling body 62 configured to selectively engage a correspondingfeature of the stented prosthetic heart valve 22, for example theconnection bodies 44 described above.

The tip 58 can assume a variety of formats, and is generally constructedto facilitate atraumatic placement of the transcatheter valve system 20through a patient's vasculature and heart. The handle 60 is mounted orconnected to a proximal end of the carrier shaft 54, and provides aconvenient surface for grasping by a clinician.

The sheath assembly 52 generally includes at least one tube or sheath 70and a handle 72. The tube 70 can be of a conventional catheter-likeconfiguration (e.g., biocompatible polymer with or without anencapsulated wire braiding) and forms at least one lumen 74. The lumen74 is sized to slidably receive the carrier shaft 54 as well as thestented prosthetic heart valve 22 in the collapsed arrangement. In someconstructions, the tube 70 can be constructed of two (or more) sections,including a reinforced capsule or capsule section 76 configured toretain the stented prosthetic heart valve 22 in the compressedarrangement. Regardless, the tube 70 is generally compliant, and is ableto traverse the tortuous pathways associated with transcatheter heartvalve implantation. The handle 72 can assume a wide variety of forms,and is generally mounted or connected to a proximal end of the tube 70.Though not shown, a flush port is provided with one or both of thehandles 60, 72 for delivering a flushing liquid into the tube 70 atleast in a region of the capsule 76.

The delivery device 24 is operable to deliver or implant the stentedprosthetic heart valve 22 as follows. FIGS. 1A and 1B illustrate thetranscatheter valve system 20 in a loaded state, including the stentedprosthetic heart valve 22 fully contained within the tube 70 of thedelivery device 24, prior to deployment. For example, the stentedprosthetic heart valve 22 is connected to the carrier shaft 54 (e.g.,engagement between the connection bodies 44 and the coupling body 62),and is radially constrained within the tube 70. The delivery device 24is configured to transition from the loaded state in which the tube 70encompasses the stented prosthetic heart valve 22 to a deployed state inwhich the tube 70 is withdrawn from the stented prosthetic heart valve22.

For aortic valve replacement procedures, the transcatheter valve system100 is, in the loaded state, advanced toward the implantation targetsite, for example in a retrograde manner through a cut-down in thefemoral artery and into the patient's descending aorta. The system 10 isthen advanced, under fluoroscopic guidance, over the aortic arch,through the ascending aorta, and midway across the defective aorticvalve. The tube 70 is partially retracted relative to the stentedprosthetic heart valve 22 as shown in FIG. 1C. For example, the handle72 provided with the sheath assembly 52 is retracted toward the handle60 of the shaft assembly 50. As shown, a portion of the stent 30 is thusexteriorly exposed relative to the tube 70 and begins to self-deploy.This proximal retraction of the tube 70 continues, with a continuallyincreasing length of the stented prosthetic heart valve 22 being exposedand thus partially deployed, until the prosthesis 22 is fully deployedin the native valve.

As indicated above, the stented prosthetic heart valve 22 is loadedwithin the delivery device 24 in a loaded state of the transcatheterheart valve system 20. Any air bubbles in the lumen 74 should be removedprior to the implantation procedure. The devices and methods of thepresent disclosure are useful in accomplishing both steps.

One embodiment of a loading device 100 in accordance with principles ofthe present disclosure is shown in FIG. 3 and includes a housing 102, afirst sealing apparatus 104, a second sealing apparatus 106, and a port108. Details on the various components are provided below. In generalterms, the housing 102 is configured to receive a stented prostheticheart valve (e.g., any of the stented prosthetic heart valves 22 (FIG.2A) described above), and the sealing apparatuses 104, 106 areconfigured to selectively establish a liquid-tight seal with componentsof a delivery device (e.g., any of the delivery devices 24 (FIG. 1B)described above). The port 108 provides a conduit through which a vacuumcan be drawn within the housing 102 as part of a flushing operation.Following flushing, the loading device 100 promotes loading of thestented prosthetic heart valve to the delivery device in an environmentfree of air bubbles.

The housing 102 is relatively rigid (e.g., hardened plastic or metal)and defines a chamber 120. The housing 102 extends between opposing,first and second ends 122, 124, and defines an opening to the chamber120 at each of the ends 122, 124. In some embodiments, the housing 102forms the chamber 120 to have a size and shape corresponding with a sizeand shape of the stented prosthetic heart valve (not shown) to beutilized with the loading device 100. For example, the housing 102 canbe characterized as defining a prosthesis segment 130 and a neck segment132. The prosthesis segment 130 extends from the second end 124 andforms the corresponding portion of the chamber 120 to have an increasingdiameter in a direction of the first end 122 (e.g., the prosthesissegment 130 can have a funnel-like shape). With additional reference toFIG. 2A, a size and shape of the prosthesis segment 130 generallycorresponds with that of the stented prosthetic heart valve 22 in, ornear, the normal, expanded arrangement. More particularly, the diameterof the chamber 120 along the prosthesis segment 130 approaches orapproximates the diameter of the outflow region 42 of the stentedprosthetic heart valve 22 in the normal, expanded arrangement.Conversely, a diameter of the prosthesis segment 130 at leastimmediately adjacent the second end 124 is less than a diameter of thestented prosthetic heart valve 22 in the normal, expanded arrangement.As made clear below, then, the chamber 120 can be configured toeffectuate partial collapse or crimping of the stented prosthetic heartvalve 22 at the second end 124 and along a portion of the prosthesissegment 130 immediately adjacent the second end 124.

The neck segment 132 extends from the prosthesis segment 130, and has areduced or tapering diameter in a direction of the first end 122 in someembodiments. Because the chamber 120 is sized and shaped to receive amajority, alternatively an entirety, of the stented prosthetic heartvalve 22 within the prosthesis segment 130, the reduced diameter of theneck segment 132 does not affect substantial, if any, collapse orcrimping of the stented prosthetic heart valve 22 as described below.

In some embodiments, the housing 102 consists of two (or more) housingsections 140, 142. The housing sections 140, 142 can take various forms,and are configured to be selectively assembled to, and disassembledfrom, one another, and collectively define the chamber 120 upon finalassembly. In this regard, the valve loading device 100 can include oneor more additional components that maintain a liquid-tight seal betweenthe housing sections 140, 142 upon final assembly (e.g., one or moregaskets, fasteners, etc.). Further, the housing sections 140, 142 caninclude various complimentary features that promote mated assembly.

The first sealing apparatus 104 is associated with the first end 122 ofthe housing 102 (e.g., is assembled to the housing 102 at or immediatelyadjacent the first end 122) and is configured to selectively seal theopening at the first end 122 relative to a corresponding component ofthe delivery device 22 (FIG. 1B) as described below. The second sealingapparatus 106 is similarly associated with the second end 124 of thehousing 102 (e.g., is assembled to the housing 102 at or immediatelyadjacent the second end 124) and is configured to selectively seal theopening at the second end 124 relative to a corresponding component ofthe delivery device 22 as described below.

In some embodiments, the first and second sealing apparatuses 104, 106can be identical, and each includes a valve (not shown). The valve canbe a hemostasis valve and in some embodiments is a Tuohy-Borst valve.Other valve constructions, such as a duckbill valve, a pinhole valve, aslit valve, etc., are also envisioned. In some constructions, one orboth of the sealing apparatuses 104, 106 include a mechanism orstructure that allows a user to selectively actuate and release thevalve relative to the corresponding delivery device component.

For reasons made clear below, in some embodiments the port 108 islocated along the neck segment 132. Regardless, the port 108 is fluidlyopen to the chamber 120. In some embodiments, a check valve 150 (e.g. aLuer-lock adaptor) is provided with, or forms, the port 108.

Use of the valve loading device 100 in performing a transcatheter heartvalve system flushing and loading operation initially includes seatingthe stented prosthetic heart valve 22 within the chamber 120 asgenerally reflected in FIG. 4A. As a point of reference, the housing 102is illustrated as being transparent in the view of FIGS. 4A-4E to showan interior thereof. Placement of the stented prosthetic heart valve 22can be accomplished in various fashions as a function of the particularconfiguration of the housing 102. For example, where the housing 102includes the first and second housing section 140, 142, the firsthousing section 140 can initially be removed from the second housingsection 142, allowing the stented prosthetic heart valve 22 to be moreeasily inserted into the second housing section 142. The first housingsection 140 is then assembled to the second housing section 142 tocomplete the housing 102. Regardless, and as generally reflected by FIG.4A, in some embodiments the chamber 120 is sized and shaped such thatonly portion of the stented prosthetic heart valve 22 is forced to ortoward a collapsed arrangement (e.g., the outflow region 42), whereasother portions of the prosthesis 22 are subjected to lessened, if any,compressive forces. The connection bodies 44 provided with the stentedprosthetic heart valve 22 extend beyond, or are otherwise accessible at,the second end 124.

The delivery device 24 is then connected to the stented prosthetic heartvalve 22 as shown in FIG. 4B. In particular, the shaft assembly 50 isdistally advanced relative to sheath assembly 52, locating the tip 58distally beyond the stented prosthetic heart valve 22. The connectorshaft 56 is located within the chamber 120, and the delivery device 24captures the connection bodies 44 (FIG. 4A) of the prosthesis 22. Forexample, though hidden in the view of FIG. 4B, the connection bodies 44are forced into captured engagement with the coupling body 62 (FIG. 1B)within the tube 70.

With reference to FIG. 4C, the first sealing apparatus 104 is thenoperated to establish a liquid-tight seal with the tip 58, and thesecond sealing apparatus 106 is operated to establish a liquid-tightseal with an exterior surface of the tube 70. Thus, the chamber 120 issealed at the openings of the first and second housing ends 122, 124(but is open to the lumen 74 (FIG. 1B) of the tube 70), and encloses thestented prosthetic heart valve 22.

A flushing operation is then performed as reflected by FIG. 4D. Salineor other liquid 160 (referenced generally) is delivered through thelumen 74 (FIG. 1B), for example via a flush port or similar assembly(not shown) located at a proximal side of the delivery device 24. Theliquid 160 traverses through the lumen 74 and enters the chamber 120.With the valve loading device 100 in the upright orientation shown inFIG. 4D, the liquid 160 fills a substantial volume, but not an entirety,of the chamber 120. A fill line 162 of the liquid 160 is establishedabove or beyond the prosthesis 22 but below the port 108. Thus, an aircavity 164 is generated, with the port 108 being fluidly open to the aircavity 164. The proximal side flush port(s) is then closed and a vacuuminstrument 170 is assembled to the port 108. The vacuum instrument 170can assume a variety of forms, for example a syringe, and can beconsidered a component of the valve loading device 100. The vacuuminstrument 170 is operated to establish a negative pressure or vacuum inthe chamber 120. The negative pressure causes a volumetric expansion ofthe air within the chamber 120 and thus a pressure drop in the chamber120 and the delivery device lumen 74. This pressure drop, in turn,facilitates removal of air bubbles 180 from the liquid 160. Typically,this is seen as smaller air bubbles in the system 20 expand under thereduced pressure, sometimes coalesce with other nearby air bubbles, andmove through the system 20 and into the air cavity 164. The check valve150 (FIG. 3) prevents liquid (and possibly air bubbles) from flowingback into the chamber 120 from the vacuum instrument 170.

Once the clinician is satisfied that the air bubbles 180 have beensufficiently flushed, the transcatheter heart valve system 20 istransitioned to the loaded state. The chamber 120 remains substantiallyfilled with the liquid 160 (but is now free of the air bubbles 180),with the fill line of the liquid 160 being beyond the prosthesis 22. Thefirst sealing apparatus 104 is slightly released relative to the tip 58.As shown in FIG. 4E, the shaft assembly 50 (referenced generally) canthen be retracted relative to the sheath assembly 52, bringing thestented prosthetic heart valve 22 (hidden in FIG. 4E) fully within thetube 70. The tapered shape of the prosthesis segment 132 assists in“funneling” the prosthesis 22 into the tube 70. Alternatively, thesecond sealing apparatus 106 can be slightly released relative to thetube 70 and the sheath assembly 52 advanced. As shown, the tip 58 hasmoved proximally into abutment with a distal end 190 of the tube 70. Thevalve loading device 100 can then be removed from the delivery device24, with the transcatheter heart valve system 20 (referenced generally)now in the loaded state and properly prepared for an implantationprocedure.

Because the valve loading device 100 is configured in accordance withcorresponding features of the delivery device 24 to effectuate theliquid-tight seals described above, in some embodiments the presentdisclosure can be viewed as providing a flushing and loading assembly200 that includes the delivery device 24 and the valve loading device100. In a flushing state of the assembly 200, the valve loading device100 is mounted to the delivery device 24, including liquid-tight sealedengagement at the first and second ends 122, 124 of the housing 102 asdescribed above. In a loading state of the assembly 200, the valveloading device 100 remains connected to the delivery device 24, but in amanner permitting manipulation of the delivery device 24 in loading thestented prosthetic heart valve 22 into the delivery device. Finally, ina delivery state of the assembly 200, the valve loading device 100 isentirely removed from the delivery device 24 so that the delivery device24 is available to perform valve implantation.

Devices, assemblies and methods of the present disclosure provide amarked improvement over previous designs. Removal of air bubbles from atranscatheter heart valve system is readily performed by creating anegative pressure or vacuum in the system (as compared to conventionaltechniques whereby flushing relies solely upon the flushing liquid beingpushed through the system). Further, an air bubble-free, liquid immersedenvironment is created in which the stented prosthetic heart valve canbe loaded into the delivery device's capsule, sheath or other tube,thereby minimizing the possibility that new air bubbles will begenerated during loading.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure.

1-14. (canceled)
 15. A method of preparing a transcatheter heart valvesystem, including a delivery device and a stented prosthetic heartvalve, for the performance of a transcatheter valve implantationprocedure, the method comprising: seating a stented prosthetic heartvalve within a chamber defined by a housing of a valve loading device,the housing extending between opposing, first and second ends anddefining an opening to the chamber at the each of the first and secondends; connecting a first component of a delivery device to the stentedprosthetic heart valve; sealing the first and second openings relativeto the delivery device; dispensing a liquid through the delivery deviceand into the chamber; creating a negative pressure in the chamber toremove air bubbles entrained in the liquid; capturing the stentedprosthetic heart valve within the delivery device; and removing thevalve loading device from the delivery device.
 16. The method of claim15, wherein the delivery device further includes a tube defining a lumenand a shaft disposed within the lumen, the shaft connect to a tiplocated distal the tube, and further wherein the step of sealing thefirst and second openings includes establishing a seal at the tip and aseal at the tube.
 17. The method of claim 16, wherein the firstcomponent is a coupling body, carried by the shaft and configured tomate with a corresponding component of the stented prosthetic heartvalve.
 18. The method of claim 17, wherein the step of capturing thestented prosthetic heart valve within the delivery device includes:releasing the seal at the tip; and retracting the shaft relative to thetube to draw the stented prosthetic heart valve into the lumen.
 19. Themethod of claim 16, wherein the stented prosthetic heart valve isconfigured to be reversibly collapsible from a natural arrangement to acollapsed arrangement, and further wherein: following the step ofloading the stented prosthetic heart valve within the chamber and duringthe step of dispensing a liquid, at least a portion of the stentedprosthetic heart valve is distally beyond the tube and has a diametergreater than a diameter of the lumen; and following the step ofcapturing the stented prosthetic heart valve within the delivery device,the stented prosthetic heart valve is retained in the collapsedarrangement, including an entirety of the prosthetic heart valve havinga diameter not greater than a diameter of the lumen.
 20. The method ofclaim 15, wherein the loading device further includes a port open to thechamber, and further wherein the step of establishing a negativepressure in the chamber includes operating a vacuum instrument connectedto the port, the port being located distal the stented prosthetic heartvalve.
 21. The method of claim 15, wherein the housing includes firstand second housing section, and further wherein the step of seating thestented prosthetic heart valve within the chamber includes: loading thestented prosthetic heart valve within the second housing section,including the first housing section being separated from the secondhousing section; and assembling the first housing section to the secondhousing section to complete the chamber.